MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 4; DERMAL FILLER

Lot Number TPUL-212426A0

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Skin Infection (4544)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

Additional mfr narrative: data batch review: the batch data review was compliant with the applicable specifications.No element allows us to identify a defect in either the quality or the safety of this teosyal rha 4 (tpul-212426a0) product.Data batch history: no other complaint was registered to date ((b)(6)2022) with this batch number.

Event Description

This case occurred outside of the usa, in (b)(6).According to information as of (b)(6) 2022, a patient was injected on (b)(6)2022, with 2 ml of teosyal puresense ultra deep (tsul-212223b0) into the bilateral palpebromalar and nasojugal groove (object of the complaint(b)(4)), and with 1 ml of teosyal rha 4 (tpul-212426a0) into the bilateral nasolabial folds (object of this complaint).Two days later, the patient presented with inflammation and skin induration on the right nasolabial fold, and as a corrective action, she received antibiotic treatment.Following receipt of this complaint, a local medical expert was put in contact with the physician to advise on this case.On feb.16, 2022, we were informed that the patient being suffering from an autoimmune disease (psoriasis), the medical expert suspected the presence of the local infection, and subsequently, he prescribed a combined antibiotic treatment (augmentin and ciprofoxacine for 7 days).On feb.22, 2022, we were informed that in addition to the pathology of psoriasis, the patient also suffered from diabetes, and for this purpose, she was hospitalized to receive appropriate antibiotic treatment against the local infection.According to our latest information on (b)(6) 2022, the symptoms have completely subsided, the patient was fine, only a small scar presented on the affected area which according to the physician will have disappeared without further complication.

• Brand Name: TEOSYAL RHA 4
• Type of Device: DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer Contact: nicolas caill ; rue de lyon; 105; geneva 1203 ; CH 1203 ; 022344-963
• MDR Report Key: 13711746
• MDR Text Key: 286863720
• Report Number: 3005975625-2022-00077
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: P170002,
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Lot Number: TPUL-212426A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female